RadiaBlock: Package Insert and Label Information

RADIABLOCK- oxybenzone and octinoxate lipstick
Medline Industries, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Oxybenzone 3%

Padimate O 7%

Purpose

Sunscreen

Sunscreen

Uses

Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reaaply at least every 2 hours

Children under 6 months: Ask a doctor

Principal Display Panel

SPF 15 Lip Balm

NDC 53329-094-83

Carrington

RadiaBlock

Sunscreen SPF 15

Net Wt: .015 oz/4.2g

RADIABLOCK oxybenzone, octinoxate lipstick

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-094 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (OXYBENZONE) OXYBENZONE 30 mg in 1 g OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 g

Inactive Ingredients Ingredient Name Strength COCOA BUTTER .ALPHA.-TOCOPHEROL CORN OIL VITAMIN A PALMITATE ALOE VERA LEAF BUTYLATED HYDROXYANISOLE CITRIC ACID MONOHYDRATE CARNAUBA WAX MINERAL OIL PARAFFIN PETROLATUM PROPYL GALLATE JOJOBA OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53329-094-83 4.2 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2013

Labeler — Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Operations
Bentley Laboratories, LLC		068351753	manufacture (53329-094)

Revised: 12/2017 Medline Industries, Inc.